CLASS II Drug recall · Reported 22 Aug 2018 · FDA Enforcement Report
Valsartan, 160 mg recalled by Northwind Pharmaceuticals
Northwind Pharmaceuticals is recalling Valsartan, 160 mg per, distributed in Indiana. The recall was initiated on 18 Jul 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1095-2018
- FDA event ID
- 80703
- Recalling firm
- Northwind Pharmaceuticals, Indianapolis, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Jul 2018
- FDA classified
- 15 Aug 2018
- Reported
- 22 Aug 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 18 Jul 2018 | Recall initiated by company | |
| 15 Aug 2018 | Classified by FDA | +28 days |
| 22 Aug 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Valsartan, 160 mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-460-52
Where it was distributed
Indiana
Questions about this recall
Is Valsartan, 160 mg per recalled?
Yes. Northwind Pharmaceuticals recalled Valsartan, 160 mg per on 18 Jul 2018. The recall is Class II and its status is Terminated. Recall number D-1095-2018.
Why was it recalled?
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Which lots are affected?
Lot: UT48320002, exp 07/31/2018; Lot UT48320003, exp 05/31/2019
Where was it sold?
Indiana
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Northwind Pharmaceuticals
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sulfamethoxazole and Trimethoprim Tablets recalledSulfamethoxazole And Trimethoprim | Northwind Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Glimepiride Tablets, USP 4mg recalled by Northwind PharmaceuticalsGlimepiride | Northwind Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Tadalafil Tablets, USP 5 mg recalled by Northwind PharmaceuticalsTadalafil | Northwind Pharmaceuticals | Hidden Drug Ingredients | Nationwide |
| Drug | CLASS II | Doxazosin Tablets, USP, 4mg recalled by Northwind PharmaceuticalsDoxazosin | Northwind Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Atorvastatin Calcium Tablets, USP, 10 mg recalledAtorvastatin Calcium | Northwind Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |